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FDA 510(k)

Hybrid C70

K-Number: K220579 · 2022-09-01

ApplicantDigimed Co., Ltd.
Decision Date2022-09-01
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Hybrid C70 is a medical device manufactured by Digimed Co., Ltd.. It received FDA 510(k) clearance on 2022-09-01 under approval number K220579. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hybrid C70?

Hybrid C70 is a medical device that received FDA 510(k) clearance on 2022-09-01. It is manufactured by Digimed Co., Ltd.. The 510(k) number is K220579.

When was Hybrid C70 approved by the FDA?

Hybrid C70 received FDA 510(k) clearance on 2022-09-01, under approval number K220579.

What company makes Hybrid C70?

Hybrid C70 is manufactured by Digimed Co., Ltd..

What is the FDA product code for Hybrid C70?

The FDA product code for Hybrid C70 is EHD.

Other Devices by Digimed Co., Ltd.

K181891Portable X-ray System (Model: MiniX-V, Mini X-S) K220574HYBRID S70 K221587DHX-70H, XTG-70H

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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